Biogen Inc. (Nasdaq: BIIB) today announced a new proposed
transaction with Samsung Bioepis Co., Ltd. to secure the exclusive
rights to commercialize two new ophthalmology biosimilars, SB11
referencing Lucentis®1 and SB15 referencing Eylea®2, in major
markets worldwide, including the U.S., Canada, Europe, Japan and
Australia. In addition, Biogen will acquire exclusive
commercialization rights for its anti-TNF portfolio, including
BENEPALITM (etanercept), FLIXABITM (infliximab) and IMRALDITM
(adalimumab), in China. Biogen will also acquire an option to
extend its existing commercial agreement with Samsung Bioepis for
this anti-TNF portfolio in Europe.
“We are excited about the potential to bring
biosimilars to a new therapeutic area as well as new regions around
the world with the goal of sustainably advancing broad access to
care for patients in need,” said Michel Vounatsos, Biogen’s Chief
Executive Officer. “This transaction would expand the potential for
our leading biosimilars business worldwide, while complementing
Biogen’s presence in ophthalmology.”
Biosimilars are products that have been
demonstrated to be similar in efficacy and safety to the
originator’s approved biological product, with the advantage that
they offer cost savings and promote sustainable access to
therapies. In Europe, over 180,000 patients have been treated with
a Biogen anti-TNF biosimilar, and, based on its internal estimates,
the company expects the uptake of BENEPALI, FLIXABI and IMRALDI to
generate approximately 1.8 billion Euros in healthcare cost savings
in 20193.
The proposed addition of the two ophthalmology
biosimilars complements Biogen’s expanding efforts in this
therapeutic area. Through the recent acquisition of Nightstar
Therapeutics plc, a clinical-stage gene therapy company focused on
treatments for inherited retinal disorders, Biogen acquired two
mid- to late-stage clinical assets, as well as several preclinical
programs, in ophthalmology.
Lucentis and Eylea are therapies widely used to
treat ophthalmologic conditions such as neovascular (wet)
age-related macular degeneration (AMD), macular edema following
retinal vein occlusion (RVO), diabetic macular edema (DME) and
diabetic retinopathy (DR) in patients with DME. In 2018 global
sales for Lucentis and Eylea were almost $11 billion, with more
than $5.8 billion spent in the U.S. alone4.
Chirfi Guindo, Executive Vice President and Head of Global Product
Strategy and Commercialization at Biogen, added “We believe savings
enabled by biosimilars provide payers and health systems globally
the budgetary headroom to fund innovation. According to a 2017 RAND
Report, in the U.S. alone savings generated from biosimilar uptake
could reach as high as $150 billion over a ten-year period5. We
look forward to expanding our biosimilars portfolio in major
markets worldwide.”
Under the terms of the proposed transaction,
Biogen will make a $100 million upfront payment to Samsung Bioepis.
Additionally, Biogen may pay Samsung Bioepis up to $210 million in
additional development, regulatory and sales-based milestones.
Samsung Bioepis will be responsible for development and will supply
both products to Biogen at a pre-specified gross margin.
Biogen will also obtain an option to extend the
term of its current European commercial agreement for its three
anti-TNF biosimilars by an additional five years, subject to
payment of an option exercise fee of $60 million.
Biogen will also receive exclusive
commercialization rights to BENEPALI, FLIXABI and IMRALDI in China
in exchange for a royalty on sales in that market.
Upon closing, Biogen expects to record a charge
to research and development expense of approximately $65 million
related to the $100 million upfront payment.
The proposed transaction is subject to customary
closing conditions, including the expiration of the applicable
waiting period under the Hart Scott Rodino Antitrust Improvements
Act of 1976 in the U.S. Biogen expects the deal to close in the
fourth quarter of 2019.
About BENEPALI
(etanercept)BENEPALI (etanercept), a biosimilar
referencing Enbrel®6, was approved by the European Commission (EC)
in January 2016 for the treatment of adults with moderate to severe
rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis
(ankylosing spondylitis and non-radiographic axial
spondyloarthritis) and plaque psoriasis. BENEPALI is currently
available in 25 countries in Europe and is the most prescribed
etanercept in the five largest European countries (Germany, UK,
France, Italy and Spain)7.
About FLIXABI
(infliximab)FLIXABI (infliximab), a biosimilar referencing
Remicade®8, was approved by the European Commission (EC) in May
2016 for the treatment of adults with rheumatoid arthritis, Crohn’s
disease, ulcerative colitis, ankylosing spondylitis, psoriatic
arthritis or psoriasis. FLIXABI can also be used in patients 6-17
years old with severe, active Crohn’s disease or severely active
ulcerative colitis when they have not responded to or cannot take
other medicines or treatments. FLIXABI is currently available in 17
countries in Europe9.
About IMRALDI
(adalimumab)IMRALDI (adalimumab), a biosimilar referencing
Humira®10, was approved by the European Commission (EC) in August
2017 for the treatment of rheumatoid arthritis, juvenile idiopathic
arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis,
pediatric plaque psoriasis, adult and adolescent hidradenitis
suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative
colitis and uveitis. IMRALDI is currently available in 19 countries
in Europe and is the leading adalimumab biosimilar in Germany and
in Europe11,12.
About Biogen
At Biogen, our mission is clear: we are pioneers
in neuroscience. Biogen discovers, develops, and delivers worldwide
innovative therapies for people living with serious neurological
and neurodegenerative diseases as well as related therapeutic
adjacencies. One of the world’s first global biotechnology
companies, Biogen was founded in 1978 by Charles Weissmann, Heinz
Schaller, Kenneth Murray, and Nobel Prize winners Walter Gilbert
and Phillip Sharp. Today Biogen has the leading portfolio of
medicines to treat multiple sclerosis, has introduced the first
approved treatment for spinal muscular atrophy, commercializes
biosimilars of advanced biologics, and is focused on advancing
research programs in multiple sclerosis and neuroimmunology,
neuromuscular disorders, movement disorders, Alzheimer’s disease
and dementia, ophthalmology, immunology, neurocognitive disorders,
acute neurology, and pain.
We routinely post information that may be
important to investors on our website at www.biogen.com. To
learn more, please visit www.biogen.com and follow us on
social media
– Twitter, LinkedIn, Facebook, YouTube.
About Samsung Bioepis Co.,
Ltd.Established in 2012, Samsung Bioepis is a
biopharmaceutical company committed to realizing healthcare that is
accessible to everyone. Through innovations in product development
and a firm commitment to quality, Samsung Bioepis aims to become
the world’s leading biopharmaceutical company. Samsung Bioepis
continues to advance a broad pipeline of biosimilar candidates that
cover a spectrum of therapeutic areas, including immunology,
oncology and ophthalmology.
Samsung Bioepis is a joint venture between
Samsung BioLogics and Biogen. For more information, please visit:
www.samsungbioepis.com and follow us on social media – Twitter,
LinkedIn.
Biogen Safe HarborThis news
release contains forward-looking statements, including statements
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995, relating to the potential
benefits and results that may be achieved through Biogen’s proposed
transaction with Samsung Bioepis; the anticipated completion and
timing of the proposed transaction; Biogen’s objectives and
intentions regarding the option to extend the term of its European
commercial agreement with Samsung Bioepis; when, and whether,
Biogen expects to exercise its option to extend the term of its
European commercial agreement with Samsung Bioepis; the potential
benefits, safety and efficacy of SB11 and SB15; the timing and
status of current and future regulatory filings; risks and
uncertainties associated with drug development and
commercialization, including SB11 and SB15; the potential of
Biogen’s commercial business and pipeline programs, including
BENEPALI, FLIXABI, IMRALDI, SB11 and SB15; the anticipated benefits
and potential of Biogen’s collaboration arrangements with Samsung
Bioepis; Biogen’s strategy and plans; Biogen’s capital allocation
and investment strategy; Biogen’s future financial and operating
results; and potential cost healthcare savings related to
biosimilars. These forward-looking statements may be accompanied by
words such as “aim,” “anticipate,” “believe,” “could,” “estimate,”
“expect,” “forecast,” “intend,” “may,” “plan,” “potential,”
“possible,” “will,” “would” and other words and terms of similar
meaning. Drug development and commercialization involve a high
degree of risk, and only a small number of research and development
programs result in commercialization of a product. Results in early
stage clinical trials may not be indicative of full results or
results from later stage or larger scale clinical trials and do not
ensure regulatory approval. You should not place undue reliance on
these statements or the scientific data presented.
These statements involve risks and uncertainties
that could cause actual results to differ materially from those
reflected in such statements, including without limitation, risks
that the proposed transaction will be completed in a timely manner
or at all; the possibility that certain closing conditions to the
proposed transaction will not be satisfied; uncertainty as to
whether the anticipated benefits of the proposed transaction and/or
the Samsung Bioepis joint venture can be achieved; risks of
unexpected costs or delays; uncertainty of success in the
development and potential commercialization of SB11 and SB15, which
may be impacted by, among other things, the occurrence of adverse
safety events, unexpected concerns that may arise from additional
data or analysis, failure to obtain regulatory approvals in certain
jurisdictions, failure to protect and enforce data, intellectual
property and other proprietary rights and uncertainties relating to
intellectual property claims and challenges; risks of legal
actions, regulatory scrutiny or other challenges to biosimilars;
the risks of other unexpected hurdles; the risks of doing business
internationally, including currency exchange rate fluctuations;
product liability claims; and third party collaboration risks. The
foregoing sets forth many, but not all, of the factors that could
cause actual results to differ from Biogen’s expectations in any
forward-looking statement. Investors should consider this
cautionary statement, as well as the risk factors identified in
Biogen’s most recent annual or quarterly report and in other
reports Biogen has filed with the U.S. Securities and Exchange
Commission. These statements are based on Biogen’s current beliefs
and expectations and speak only as of the date of this news
release. Biogen does not undertake any obligation to publicly
update any forward-looking statements, whether as a result of new
information, future developments or otherwise.
1Lucentis is a registered trademark of
Genentech. 2Eylea is a registered trademark of Regeneron
Pharmaceuticals, Inc.3Biogen data on file.4Source: company reported
sales, EvaluatePharma.5Mulcahy, Andrew W., Jakub P. Hlavka, and
Spencer R. Case, Biosimilar Cost Savings in the United States:
Initial Experience and Future Potential. Santa Monica, CA: RAND
Corporation, 20176Enbrel is a registered trademark of Wyeth
LLC.7Data on file: IQVIA, GERS, Insight Health ODV.8Remicade is a
registered trademark of Janssen Biotech, Inc.9Data of file: IQVIA,
GERS, Insight Health ODV.10Humira is a registered trademark of
AbbVie Biotechnology Ltd.11Data on file: IQVIA, GERS, Insight
Health ODV.12Biogen data on file.
BIOGEN MEDIA CONTACT: David Caouette +1 617 679 4945
public.affairs@biogen.com |
BIOGEN INVESTOR CONTACT: Joe Mara +1 781 464 2442
IR@biogen.com |
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